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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Description of key information

LC50 (14 d) > 1000 mg/kg dw for Eisenia fetida (OECD 207/EU Method C.8)

Key value for chemical safety assessment

Additional information

Since no studies investigating the toxicity to soil macroorganisms of ethylene distearate (CAS 627-83-8) are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to two structurally related category members butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.3) and within the category justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment. Nevertheless, as it can be seen in the data matrix of the category justification in section 13 and the overall summary, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

The first study with butylene glycol dicaprylate / dicaprate was performed according to OECD 207 under GLP conditions (Lührs, 2001). Eisenia fetida was exposed to 5 different test substance concentrations up to 1000 mg/kg dw in artificial soil for 14 d. Mortality and body weight were recorded at the end of the study. No mortality was observed resulting in a LC50 of > 1000 mg/kg dw. The body weight increased significantly at a test concentration of 1000 mg/kg dw. Therefore, a NOEC of 500 mg/kg dw was determined.

Eisenia foetida foetida was used in the second study according to EU Method C.8 (GLP) to evaluate the toxicity of decanoic acid, mixed diesters with octanoic acid and propylene glycol to soil macroorganisms (Scholz, 1996). A limit test with a concentration of 1000 mg/kg dw did not result in mortality after 14 d of exposure. Therefore, a LC50 > 1000 mg/kg dw was determined.

Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by an equal ecotoxicological profile, it can be concluded that ethylene distearate will not exhibit effects on soil macroorganisms.